Heli-FX EndoAnchor System

Heli-FX EndoAnchor System is an FDA 510(k)-cleared medical device (K182957) manufactured by Medtronic Vascular, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 20, 2018. Regulation: 8.